Research to build a process for production and testing of stable dry blood sample HbA1c application in external quality assessment

Abstract

To develop a standardised protocol for the production of lyophilised (freeze-dried) whole-blood samples for HbA1c testing and to evaluate the stability of these samples across varying temporal and thermal storage conditions, aiming to facilitate the localisation of external quality assessment (EQA) materials in Vietnam.This experimental study was conducted at the Department of Biochemistry, Medical Laboratory Center, Pham Ngoc Thach University of Medicine. The production protocol was validated in accordance with TCVN:9596/ISO:13528 and ISO:35 standards, focusing on homogeneity and stability criteria. Two batches of lyophilised whole-blood samples were produced at different HbA1c concentration levels: 5.74%±0.05 (non-diabetic group) and 7.85%±0.07 (diabetic group). Both batches demonstrated high homogeneity. Stability evaluations over a 6-month period confirmed that both batches remained stable under storage conditions of 2-8^oC and -196^oC. The study successfully established a reliable protocol for the production of lyophilised HbA1c EQA samples, satisfying both homogeneity and stability requirements according to TCVN:9696 guidelines.